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510(k) Data Aggregation

    K Number
    K252469
    Device Name
    MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA
    Manufacturer
    DMP Dental Industry S.A.
    Date Cleared
    2025-11-06

    (92 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K192830
    Device Name
    Bright Temporary C&B
    Manufacturer
    DMP Dental Industry S.A.
    Date Cleared
    2020-09-02

    (336 days)

    Product Code
    EBG
    Regulation Number
    872.3770
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    • Temporary crowns and bridges

    • Temporary inlays and onlays

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for a dental device, "BRIGHT TEMPORARY C&B," and specifies its indications for use. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

    Therefore, I cannot provide the requested information based on the given text. The document focuses on regulatory approval based on substantial equivalence to predicate devices, not on the results of a specific performance study against defined acceptance criteria.

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